Senior Medical Writer (m/f/d)

About the role

A Senior Medical Writer is sought in Basel-Landschaft for a 24-month position. The role leads scientific writing and submissions, advises study teams on regulatory strategy, reviews data and interacts with Health Authorities, while mentoring junior writers.

Key responsibilities

• Draft, edit and finalise regulatory documents independently, including CTD Module 2 summaries, Clinical Overviews, CSRs, Investigator Brochures (IB) and Pediatric Investigational Plans (PIP)
• Advise study teams on data pooling strategies and ensure content meets global filing requirements
• Review Statistical Analysis Plans (SAPs) and the scientific integrity of data shown in CSRs
• Prepare Briefing Books, 120-day Safety Updates and formal responses to Health Authorities
• Act as central contact for stakeholders in Clinical Sciences, Biometry, Drug Safety, CMC and Regulatory Affairs
• Oversee external medical writing vendors for quality and on-time delivery
• Mentor junior writers and share knowledge internally

Required profile

• Bachelor's degree in Life Sciences (mandatory); Master's or PhD strongly preferred
• At least 5 years of regulatory/medical writing experience in the pharmaceutical industry
• Experience across indications, with a strong preference for a Cardiology background
• Full professional proficiency in English (written and verbal)

Required skills

• Deep understanding of global regulatory guidelines such as ICH-GCP and the eCTD structure
• Advanced interpersonal skills to manage complex stakeholder groups and tight deadlines